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New digital technologies that enable clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT). Read More
A group of 26 state attorneys general joined the outcry against Medicare’s ongoing payment restrictions on antiamyloid antibody Alzheimer’s therapeutics, sending a letter to HHS last week calling for full coverage of the drugs. Read More
After heated delays involving a competitor and the FDA, Dublin-based Avadel Pharmaceuticals has won FDA approval for Lumryz, its extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Read More
As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
The FDA outlined its latest thinking on developing nicotine replacement therapy (NRT) drugs in a final guidance released Monday, including detailed recommendations for clinical trials to support product applications. Read More
Astellas Pharma has acquired Iveric Bio in a $5.9 billion deal that brings the Japanese biotech Iveric’s avacincaptad pegol (ACP), an investigational intraocular injection for geographic atrophy secondary to age-related macular degeneration. Read More
Ascendis Pharma of Denmark got slapped with a Complete Response Letter (CRL) in which the FDA voiced concerns about the variability in the delivered dose of the company’s investigational treatment for adults with hypoparathyroidism. Read More
The FDA’s ability to function is threatened by the loss of public respect for the agency’s science-based decision making, which is “arguably at an all-time low,” said Steven Grossman, executive director of the Alliance for a Stronger FDA. Read More
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 1 with one abstention to recommend that the FDA restrict approval for the combination of AstraZeneca’s blockbuster cancer drug Lynparza (olaparib) and Zytiga (abiraterone) to just metastatic castration-resistant prostate cancer (mCRPC) patients whose tumors have a breast cancer gene (BRCA) mutation. Read More